Certificates and Accreditations

Primex OneVue Sense® meets or exceeds all requirements and recommendations of the CDC, TJC, and other authorities having jurisdiction (AHJs) for electronic records.

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Established by the American Institute of Certified Public Accountants (AICPA), the SOC 2 examination is designed for organizations of any size, regardless of industry and scope, to ensure the personal assets of their potential and existing customers are protected. SOC 2 reports are recognized globally and affirm that a company's infrastructure, software, people, data, policies, procedures and operations have been formally reviewed.

This certification demonstrates Primex's continued commitment to compliance and ensures customers with the confidence that required safeguards are in place to protect their data.

In addition, Primex OneVue Sense is diligently yet swiftly working toward acquiring authorization and accreditation from and complying with the following agencies:

FedRAMP

The Federal Risk and Authorization Management Program (FedRAMP) is a U.S. government program that presents a standardized approach to security assessment, authorization, and continuous monitoring for cloud-based products and services. FedRAMP enables the federal government to quickly adopt cloud computing by creating transparent standards and processes for security and authorizations while allowing agencies to leverage security authorizations on an enterprise-wide scale.

Gaining FedRAMP authorization will allow federal agencies to quickly and securely choose Primex OneVue Sense for their automated monitoring cloud-based data storage.

FDA 21 CFR Part 11

The U.S. Food and Drug Administration developed the 21 CFR Part 11 regulation to ensure the integrity, authenticity, and reliability of electronic records and signatures in regulated industries, such as pharmacy and healthcare. The regulation strives to solidify that electronic records can be trusted the same way that handwritten records and their subsequent paper signatures are trusted.

Given that Primex OneVue Sense continuously monitors, measures, and records data to the cloud-based OneVue® software, which features on-demand report generation, this accreditation will further strengthen the already existing trust Primex garners from healthcare users.